Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

The oncolytic virus cancer therapy market is poised for significant growth, driven by increasing research and development of genetically engineered viruses that selectively target and destroy cancer cells while stimulating anti-tumor immune responses. The expanding clinical pipeline of therapies such as Cretostimogene grenadenorepvec (CG Oncology), CAN-2409 (Candel Therapeutics), AdAPT-001 (EpicentRx), LOAd703 (Lokon Pharma), RP1 (Replimune), VG 161 (Virogin Biotech), RP2 (Replimune), and others are expected to further accelerate market growth.. 溶瘤病毒癌症治疗市场有望实现显著增长，其驱动力在于针对基因工程病毒的研發日益增加，这些病毒能够选择性靶向并摧毁癌细胞，同时激发抗肿瘤免疫反应。随着Cretostimogene grenadenorepvec（CG Oncology公司）、CAN-2409（Candel Therapeutics公司）、AdAPT-001（EpicentRx公司）、LOAd703（Lokon Pharma公司）、RP1（Replimune公司）、VG 161（Virogin Biotech公司）、RP2（Replimune公司）等疗法临床管线的不断扩展，预计将进一步加速市场增长。LAS VEGAS 拉斯维加斯, ，Aug. 26, 2026 2026年8月26日/PRNewswire/ --DelveInsight's Oncolytic Virus Cancer Therapy Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Melanoma, Biliary Tract Cancer, Head and Neck Cancer, Pancreatic Cancer, NSCLC, Hepatocellular Carcinoma, Breast Cancer, Prostate Cancer, Brain Cancer, Bladder Cancer, Ovarian Cancer, and others. /PRNewswire/ -- DelveInsight的《溶瘤病毒癌症治疗市场规模、目标人群、竞争格局与市场预测》报告全面剖析了当前的治疗实践和可覆盖的患者人群，涵盖黑色素瘤、胆道癌、头颈癌、胰腺癌、非小细胞肺癌、肝细胞癌、乳腺癌、前列腺癌、脑癌、膀胱癌、卵巢癌等主要适应症及其他适应症。The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging oncolytic virus cancer therapy, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets (the US, EU4, UK, and Japan).. 所选适应症基于已获批的疗法和正在进行的研发管线活动。报告还提供了对新兴溶瘤病毒癌症疗法的洞察、各疗法的市场份额，以及2022年至2036年期间当前和预测的市场规模，并按领先市场（美国、欧盟四国、英国和日本）进行细分。Key Takeaways from the Oncolytic Virus Cancer Therapy Market Report 溶瘤病毒癌症治疗市场报告的关键要点The market size for oncolytic virus cancer therapywas found to be 溶瘤病毒癌症疗法的市场规模被发现为USD 177 million 1.77亿美元in the 7MM in 2025. 在2025年的7MM中。The United States accounted for the largest oncolytic virus immunotherapy marketsize of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. 2025年，在七大主要市场（7MM）中，美国占溶瘤病毒免疫疗法市场规模的份额最大，高于其他主要市场，包括欧盟四国（德国、法国、意大利和西班牙）、英国和日本。The report provides the total potential number of patients in the indications, such as 该报告提供了各适应症中潜在患者总数，例如Melanoma, Biliary Tract Cancer, Head and Neck Cancer, Pancreatic Cancer, NSCLC, Hepatocellular Carcinoma, Breast Cancer, Prostate Cancer, Brain Cancer, Bladder Cancer, Ovarian Cancer, and others 黑色素瘤、胆道癌、头颈癌、胰腺癌、非小细胞肺癌、肝细胞癌、乳腺癌、前列腺癌、脑癌、膀胱癌、卵巢癌等. 。Oncolytic virus therapies are primarily being developed to treat cancers in relapsed refractory settings. Consequently, these therapies could address nearly 溶瘤病毒疗法主要正在被开发用于治疗复发难治性癌症。因此，这些疗法可以解决几乎20% 百分之二十of all cancer cases, providing a significant treatable patient pool. 占所有癌症病例的很大一部分，提供了可观的可治疗患者群体。Leading oncolytic virus companies, such as 领先的溶瘤病毒公司，例如CG Oncology, Candel Therapeutics, EpicentRx, Lokon Pharma, Replimune, Virogin Biotech, Binhui Bio, Genelux, Imugene, BioInvent, Transgene, Oncolytics Biotech, CG Oncology、Candel Therapeutics、EpicentRx、Lokon Pharma、Replimune、Virogin Biotech、滨会生物、Genelux、Imugene、BioInvent、Transgene、Oncolytics Biotech，and others, are developing novel oncolytic virus cancer therapiesthat can be available in the oncolytic virus therapy marketin the coming years. 以及其他机构正在开发新型溶瘤病毒癌症疗法，这些疗法有望在未来几年内进入溶瘤病毒治疗市场。Some of the key oncolytic virus cancer therapiesin clinical trials include 临床试验中一些关键的溶瘤病毒癌症疗法包括Cretostimogene grenadenorepvec, CAN-2409, AdAPT-001, LOAd703, RP1, RP2, VG 161, BS001, Olvi-Vec, CF33, BT-001, TG6050, Pelareorep, Cretostimogene grenadenorepvec、CAN-2409、AdAPT-001、LOAd703、RP1、RP2、VG 161、BS001、Olvi-Vec、CF33、BT-001、TG6050、Pelareorep，and others. 以及其他。Discover real-time oncolytic virus analysis @ 发现实时溶瘤病毒分析 @https://www.delveinsight.com/report-store/oncolytic-virus-cancer-therapy-market https://www.delveinsight.com/report-store/oncolytic-virus-cancer-therapy-marketKey Factors Driving the Oncolytic Virus Cancer Therapy Market 推动溶瘤病毒癌症治疗市场的关键因素Growing Adoption of Novel Cancer Immunotherapies: 新型癌症免疫疗法的日益普及：The increasing shift toward innovative immuno-oncology approaches is driving interest in oncolytic virus therapies. These treatments can selectively infect and destroy tumor cells while also stimulating broader antitumor immune responses. 日益向创新免疫肿瘤学方法的转变，正推动人们对溶瘤病毒疗法的兴趣。这些疗法能够选择性感染并摧毁肿瘤细胞，同时激发更广泛的抗肿瘤免疫反应。Rising Cancer Burden Worldwide: 全球癌症负担日益加重：The growing incidence of cancer and the need for more effective treatment options are creating demand for alternative therapeutic modalities. Oncolytic viruses offer a promising approach, particularly for patients with advanced or treatment-resistant cancers. 癌症发病率的不断上升以及对更有效治疗方案的需求，正在推动对替代性治疗方式的需求。溶瘤病毒提供了一种颇具前景的治疗途径，尤其适用于晚期或耐药性癌症患者。Advancements in Viral Engineering Technologies: 病毒工程技术进展：Progress in genetic engineering is enabling the development of more targeted and potent oncolytic viruses. Researchers can modify viral platforms to improve tumor selectivity, enhance immune activation, and deliver therapeutic genes directly to cancer cells. 基因工程的进步使得开发更具靶向性和更强效的溶瘤病毒成为可能。研究人员可以对病毒平台进行改造，以提高肿瘤选择性、增强免疫激活，并将治疗基因直接递送至癌细胞。Increasing Clinical Development and Pipeline Activity: 临床开发及管线活动日益增加：Pharmaceutical and biotechnology companies are expanding their oncolytic virus therapy pipelines across multiple tumor types. Growing clinical trial activity of therapies such as 制药和生物技术公司正在扩展其溶瘤病毒疗法在多种肿瘤类型中的研发管线。诸如以下疗法的临床试验活动日益增多：Cretostimogene grenadenorepvec 克雷托刺激基因格瑞纳多诺普维克(CG Oncology), (CG Oncology),CAN-2409 CAN-2409(Candel Therapeutics), （Candel Therapeutics）AdAPT-001 AdAPT-001(EpicentRx), （EpicentRx）LOAd703 LOAd703(Lokon Pharma), （Lokon Pharma）RP1 RP1(Replimune), （Replimune），VG 161 VG 161(Virogin Biotech), and others, andencouraging efficacy data are supporting greater investment and market interest. （Virogin Biotech）等公司，以及令人鼓舞的疗效数据正推动着更多的投资和市场关注。Aparna Thakur, an oncology expert at DelveInsight, said that with ongoing advancements and strategic collaborations, oncolytic viruses are positioned to play a pivotal role in the future of oncology, providing patients with new hope and facilitating the development of more effective and personalized cancer therapies.. DelveInsight 的肿瘤学专家阿帕尔纳·塔库尔（Aparna Thakur）表示，随着持续的技术进步和战略合作，溶瘤病毒有望在肿瘤学的未来发展中发挥关键作用，为患者带来新希望，并推动更有效、更个性化的癌症疗法的开发。Oncolytic Virus Cancer Therapy Market Analysis 溶瘤病毒癌症治疗市场分析报告Oncolytic viruses represent a promising immunotherapeutic approach in which viruses are used to selectively infect and eliminate cancer cells. Beyond their inherent tumor-targeting properties, these viruses can be genetically engineered to introduce therapeutic genes into malignant cells, thereby enhancing their antitumor activity.. 溶瘤病毒代表了一种前景广阔的免疫治疗方法，通过利用病毒选择性感染并清除癌细胞。除了其固有的肿瘤靶向特性外，这些病毒还可以通过基因工程改造，将治疗性基因导入恶性肿瘤细胞，从而增强其抗肿瘤活性。In 2015, 2015年，IMLYGIC IMLYGICbecame the first oncolytic virus to receive U.S. FDA approval for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that had recurred following initial surgery. 成为首个获得美国食品药品监督管理局（FDA）批准、用于局部治疗初治手术后复发的黑色素瘤患者不可切除的皮肤、皮下及淋巴结病变的溶瘤病毒。Subsequently, in June 2021, 随后，在2021年6月，DELYTACT 德立他克(teserpaturev/G47∆; Daiichi Sankyo) obtained conditional and time-limited approval from Japan's Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with malignant glioma. (teserpaturev/G47∆；第一三共) 获得了日本厚生劳动省（MHLW）针对恶性胶质瘤患者治疗的有条件且限时批准。A diverse range of oncolytic virus platforms is currently being investigated in clinical development, including adenoviruses, herpes simplex viruses, Maraba viruses, measles viruses, Newcastle disease viruses, picornaviruses, reoviruses, vaccinia viruses, vesicular stomatitis viruses, and other viral platforms.. 目前，多种溶瘤病毒平台正处于临床开发研究阶段，包括腺病毒、单纯疱疹病毒、马拉巴病毒、麻疹病毒、新城疫病毒、小核糖核酸病毒、呼肠孤病毒、痘苗病毒、水疱性口炎病毒以及其他病毒平台。Encouraging clinical trial outcomes across multiple cancer types, including melanoma, bladder cancer, biliary tract cancer (BTC), glioblastoma, ovarian cancer, pancreatic cancer, and other solid tumors, have further accelerated interest in and development of these emerging therapeutic modalities. 在包括黑色素瘤、膀胱癌、胆道癌（BTC）、胶质母细胞瘤、卵巢癌、胰腺癌及其他实体瘤在内的多种癌症类型中，临床试验结果令人鼓舞，进一步加速了人们对这些新兴治疗模式的兴趣及其开发进程。As a result, the oncolytic virus therapy (OVT) pipeline is expanding rapidly, with companies such as 因此，溶瘤病毒疗法（OVT）的研发管线正在迅速扩张，诸如Genelux Genelux(Olvi-Vec), （奥尔维-维克）Candel Therapeutics 坎德尔治疗公司(CAN-2409), (CAN-2409),CG Oncology CG肿瘤学(cretostimogene grenadenorepvec), （克雷托刺激基因 格雷纳多雷普维克）Oncolytics Biotech Oncolytics Biotech(pelareorep), （佩拉雷奥雷普）Replimune Replimune(RP1), (RP1)，Lokon Pharma 洛康制药(LoAd703), (LoAd703),Imugene 伊姆基因(CF33), and (CF33)，以及SillaJen 希拉珍(Pexa-Vec [JX-594]) advancing candidates through clinical development. (Pexa-Vec [JX-594]) 推进候选药物通过临床开发。In parallel, SillaJen is progressing next-generation oncolytic immunotherapy candidates, including the SJ-600 and JX-900 series, further highlighting ongoing efforts to develop innovative virus-based treatments for cancer. 与此同时，SillaJen 正在推进下一代溶瘤免疫疗法候选药物（包括 SJ-600 和 JX-900 系列）的研发，进一步凸显了其在开发创新型病毒基癌症治疗手段方面的持续努力。Learn more about the hydroxychloroquine oncolytic virus cancer therapy@ 了解更多关于羟氯喹溶瘤病毒癌症疗法的信息 @Oncolytic Virus Analytics 溶瘤病毒分析Oncolytic Virus Cancer Therapy Competitive Landscape 溶瘤病毒癌症治疗竞争格局Some of the oncolytic viruses under development include 正在开发的一些溶瘤病毒包括Cretostimogene grenadenorepvec 克雷托刺激基因格雷纳登诺雷普韦克(CG Oncology), （CG Oncology）CAN-2409 CAN-2409(Candel Therapeutics), (Candel Therapeutics),AdAPT-001 AdAPT-001(EpicentRx), (EpicentRx)LOAd703 LOAd703(Lokon Pharma), （洛康制药）RP1 RP1(Replimune), (Replimune),VG 161 VG 161(Virogin Biotech), （Virogin Biotech），RP2 RP2(Replimune), (Replimune),BS001 BS001(Binhui Bio), （滨辉生物）Olvi-Vec 奥尔维-维克(Genelux), （Genelux）CF33 CF33(Imugene), （Imugene）BT-001 BT-001(BioInvent/Transgene), (BioInvent/Transgene),TG6050 TG6050(Transgene), （转基因）Pelareorep 佩拉雷奥普(Oncolytics Biotech), and others. （Oncolytics Biotech）等。Genelux's Genelux的Olvi-Vec 奥尔维-维克is a genetically modified vaccinia virus with a triple mechanism of action. It directly targets and destroys cancer cells, activates a tumor-specific immune response, and transforms the tumor microenvironment from an immunosuppressive 'cold' state into an immunoreactive 'hot' state. The therapy is currently under clinical development for several cancers, including platinum-resistant/refractory ovarian cancer, recurrent non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and pancreatic cancer. 是一种具有三重作用机制的基因改造痘苗病毒。它可直接靶向并摧毁癌细胞，激活肿瘤特异性免疫反应，并将肿瘤微环境从免疫抑制性的“冷”状态转化为免疫反应性的“热”状态。该疗法目前正处于针对多种癌症的临床开发阶段，包括铂类耐药/难治性卵巢癌、复发性非小细胞肺癌（NSCLC）、小细胞肺癌（SCLC）以及胰腺癌。In November 2023, Genelux announced that the US FDA had granted . 2023年11月，Genelux宣布美国食品药品监督管理局（FDA）已授予。Fast Track Designation (FTD) 快速通道认定（FTD）to olvi-vec for its development in patients with platinum-resistant/refractory ovarian cancer. 用于其在铂类耐药/难治性卵巢癌患者中的开发。CG Oncology's Cretostimogene CG Oncology 的 Cretostimogeneis an investigational oncolytic immunotherapy administered intravesically and is being studied in the 是一种经膀胱内给药的在研溶瘤免疫疗法，目前正在研究中Phase III BOND-003 trial BOND-003 三期临床试验for patients with Bacillus Calmette–Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). It is also being evaluated as a monotherapy in the Phase III PIVOT-006 trial for patients with intermediate-risk NMIBC. The US FDA has granted both 适用于对卡介苗（BCG）无反应的非肌层浸润性膀胱癌（NMIBC）患者。该药物还在针对中危NMIBC患者的III期PIVOT-006试验中作为单药疗法进行评估。美国食品药品监督管理局（FDA）已授予两者Fast Track Designation (FTD) and Breakthrough Therapy Designation (BTD) 快速通道认定（FTD）和突破性疗法认定（BTD）to cretostimogene grenadenorepvec for the treatment of high-risk, BCG-unresponsive NMIBC with carcinoma in situ, with or without Ta or T1 papillary tumors. 用于克雷托斯替莫金（cretostimogene）grenadenorepvec 治疗伴有或不伴有 Ta 或 T1 期乳头状肿瘤的、对卡介苗（BCG）无反应的高风险非肌层浸润性膀胱癌（NMIBC），且合并原位癌。BioInvent/Transgene's BT-001 BioInvent/Transgene 的 BT-001is a drug candidate being developed through a collaboration with French biotechnology company Transgene. It is an oncolytic virus engineered to deliver BioInvent's anti-CTLA-4 antibody directly within tumors. By releasing the antibody locally as the virus infects tumor cells, BT-001 is designed to enhance tumor-targeted activity while potentially reducing systemic side effects. BT-001 是一种正在与法国生物技术公司 Transgene 合作开发的候选药物。它是一种经过工程改造的溶瘤病毒，旨在将 BioInvent 的抗 CTLA-4 抗体直接递送至肿瘤内部。通过在病毒感染肿瘤细胞时局部释放抗体，BT-001 旨在增强针对肿瘤的活性，同时可能降低全身性副作用。The candidate is currently being investigated in combination with pembrolizumab in a Phase 1/2a clinical trial.. 该候选药物正在一项1/2a期临床试验中与帕博利珠单抗联合接受调查。The anticipated launch of these emerging therapies are poised to transform the oncolytic virus market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the oncolytic virus cancer therapymarket landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.. 这些新兴疗法的预期推出，有望在未来几年重塑溶瘤病毒市场的格局。随着这些前沿疗法不断成熟并获得监管批准，预计将重构溶瘤病毒癌症治疗市场的格局，树立新的护理标准，并为医疗创新和经济增长开辟机遇。To know more about oncolytic virus therapies developers companies, visit @ 如需了解更多关于溶瘤病毒疗法开发公司的信息，请访问 @Oncolytic Virus Landscape 溶瘤病毒格局Recent Developments in the Oncolytic Virus Cancer Therapy Market 溶瘤病毒癌症治疗市场的最新进展In 在August 2026, Replimune Group, Inc. 2026年8月，Replimune Group, Inc.announced that the FDA has granted accelerated approval to TUDRIQEVTM (vusolimogene oderparepvec-wtpg), formerly known as RP1, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed following treatment with an anti-PD-1 antibody-based regimen.. 宣布美国食品药品监督管理局（FDA）已加速批准TUDRIQEVTM（vusolimogene oderparepvec-wtpg，前称RP1）联合纳武利尤单抗，用于接受抗PD-1抗体方案治疗后疾病进展的不可切除晚期皮肤黑色素瘤成人患者。In 在July 2026, UroGen Pharma Ltd. 2026年7月，UroGen Pharma有限公司announced that the FDA has cleared its Investigational New Drug (IND) application for UGN-501, a next-generation investigational oncolytic virus. The IND clearance paves the way for the initiation of a planned Phase 1 clinical trial evaluating UGN-501 in patients with non-muscle invasive bladder cancer (NMIBC).. 宣布美国食品药品监督管理局（FDA）已批准其新一代在研溶瘤病毒UGN-501的新药临床试验（IND）申请。该IND获批为启动计划中的1期临床试验铺平了道路，该试验旨在评估UGN-501在非肌层浸润性膀胱癌（NMIBC）患者中的疗效和安全性。In 在June 2026, Candel Therapeutics, Inc. 2026年6月，Candel Therapeutics, Inc.initiated the global pivotal Phase 3 AURORA trial (NCT07660094) to evaluate aglatimagene besadenovec (aglatimagene; CAN-2409) plus valacyclovir alongside continued pembrolizumab treatment in patients with metastatic non-squamous NSCLC who experienced disease progression following pembrolizumab and platinum-based chemotherapy.. 启动了全球关键性III期AURORA试验（NCT07660094），以评估在既往接受帕博利珠单抗和含铂化疗后出现疾病进展的转移性非鳞状非小细胞肺癌患者中，阿格拉蒂马基因贝沙德诺韦（阿格拉蒂马基因；CAN-2409）联合伐昔洛韦并继续帕博利珠单抗治疗的疗效。In 在May 2026, CG Oncology 2026年5月，CG Oncologyreported positive Phase II CORE-008 Cohort CX results, with cretostimogene grenadenorepvec plus gemcitabine demonstrating encouraging high-grade event-free survival (HG-EFS), high complete response (CR) rates, and favorable tolerability in high-risk NMIBC patients. The data, which demonstrate encouraging HG-EFS, high CR rates, and a well-tolerated safety profile, were presented at the Society of Urologic Oncology (SUO) Session at the 2026 American Urological Association (AUA) Annual Meeting.. 报告了CORE-008研究CX队列的阳性II期结果，在高风险非肌层浸润性膀胱癌（NMIBC）患者中，cretostimogene grenadenorepvec联合吉西他滨显示出令人鼓舞的高级别无事件生存率（HG-EFS）、较高的完全缓解（CR）率以及良好的耐受性。这些数据展现了令人鼓舞的HG-EFS、高CR率以及良好的安全性特征，并在2026年美国泌尿协会（AUA）年会的泌尿肿瘤学会（SUO）专场上发表。In 在March 2026, Genelux 2026年3月，Geneluxreported positive clinical progress for Olvi-Vec, with Phase III ovarian cancer topline data expected in 2H26, encouraging lung cancer results, and cash runway extending into 1Q27. 报告称Olvi-Vec取得积极的临床进展，预计2026年下半年公布III期卵巢癌试验的顶线数据，肺癌试验结果令人鼓舞，现金跑道延长至2027年第一季度。In 在February 2026, CG Oncology 2026年2月，CG Oncologyreported accelerated enrollment and an expedited Phase III (PIVOT-006) timeline in intermediate-risk NMIBC, with topline data expected in 1H26. The company also reported strong efficacy and durability data for cretostimogene across high-risk NMIBC cohorts, announced upcoming Phase II combination results with gemcitabine, and remains on track for a BLA submission in high-risk BCG-unresponsive NMIBC during 2026.. 报告称，在中危非肌层浸润性膀胱癌（NMIBC）患者中，入组加速，III期临床试验（PIVOT-006）时间线提前，预计2026年上半年公布主要数据。该公司还报告了cretostimogene在高危NMIBC各队列中的强劲疗效和持久性数据，宣布即将公布与吉西他滨联合使用的II期临床试验结果，并计划在2026年提交针对高危BCG无应答NMIBC的生物制品许可申请（BLA），目前进展顺利。Oncolytic Virus Cancer Therapy Epidemiology Segmentation 溶瘤病毒癌症疗法的流行病学细分The oncolytic virus market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2022–2036 across the leading markets. Effective therapies for gastrointestinal cancers are scarce, with less than 溶瘤病毒市场报告是一份全面且专业的分析，为2022–2036年研究期间的主要市场提供深入的流行病学见解。胃肠道癌症的有效疗法稀缺，不足12% 百分之十二of pancreatic cancer patients surviving beyond five years with the current standard of care. 在当前标准治疗方案下，胰腺癌患者生存期超过五年的比例。The oncolytic virus cancer therapy target patient pool is segmented into: 溶瘤病毒癌症疗法的目标患者群体细分为：Total Cases of Selected Cancer Types 选定癌症类型的总病例数Target Patient Pool of OVTs by Cancer Types 按癌症类型划分的溶瘤病毒（OVT）目标患者池Treated Cases by Cancer Types 按癌症类型分类的治疗病例Oncolytic Virus Cancer Therapy Report Metrics 溶瘤病毒癌症治疗报告指标Details 详情Study Period 学习周期2022–2036 2022–2036Oncolytic Virus Cancer Therapy ReportCoverage 溶瘤病毒癌症治疗报告覆盖范围7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] 7MM [美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本]Key Indications Covered in the Report 报告中涵盖的关键适应症Melanoma, Biliary Tract Cancer, Head and Neck Cancer, Pancreatic Cancer, NSCLC, Hepatocellular Carcinoma, Breast Cancer, Prostate Cancer, Brain Cancer, Bladder Cancer, Ovarian Cancer, and others 黑色素瘤、胆道癌、头颈癌、胰腺癌、非小细胞肺癌、肝细胞癌、乳腺癌、前列腺癌、脑癌、膀胱癌、卵巢癌及其他Oncolytic Virus Therapies Market Size in 2025 2025年溶瘤病毒疗法市场规模USD 177 Million 1.77亿美元Key Oncolytic Virus Companies 主要溶瘤病毒公司CG Oncology, Candel Therapeutics, EpicentRx, Lokon Pharma, Replimune, Virogin Biotech, Binhui Bio, Genelux, Imugene, BioInvent, Transgene, Oncolytics Biotech, Amgen, Daiichi Sankyo, and others CG Oncology、Candel Therapeutics、EpicentRx、Lokon Pharma、Replimune、Virogin Biotech、宾会生物、Genelux、Imugene、BioInvent、Transgene、Oncolytics Biotech、安进、第一三共及其他公司KeyOncolytic Virus Cancer Therapy 关键溶瘤病毒癌症疗法Cretostimogene grenadenorepvec, CAN-2409, AdAPT-001, LOAd703, RP1, RP2, VG 161, BS001, Olvi-Vec, CF33, BT-001, TG6050, Pelareorep, IMLYGIC, DELYTACT, and others Cretostimogene grenadenorepvec、CAN-2409、AdAPT-001、LOAd703、RP1、RP2、VG 161、BS001、Olvi-Vec、CF33、BT-001、TG6050、Pelareorep、IMLYGIC、DELYTACT 等Scope of the 的范围Oncolytic Virus Cancer Therapy 溶瘤病毒癌症疗法Market Report 市场报告Oncolytic Virus Cancer Therapy Patient Population Forecast 溶瘤病毒癌症治疗患者人群预测Oncolytic Virus Cancer Therapy Therapeutics Market Size 溶瘤病毒癌症治疗药物市场规模Oncolytic Virus Cancer Therapy Pipeline Analysis 溶瘤病毒癌症治疗管线分析Oncolytic Virus Cancer Therapy Market Size and Trends 溶瘤病毒癌症治疗市场规模与趋势Oncolytic Virus Cancer Therapy Market Opportunity 溶瘤病毒癌症治疗市场机遇Oncolytic Virus Cancer Therapy Market Unmet Needs 溶瘤病毒癌症治疗市场的未满足需求KOL's Views on Oncolytic Virus Cancer Therapy 关键意见领袖对溶瘤病毒癌症疗法的观点Oncolytic Virus Cancer Therapy Market Access and Reimbursement 溶瘤病毒癌症疗法的市场准入与报销Discover the oncolytic virus manufacturing analytics @ 探索溶瘤病毒制造分析 @Oncolytic Virus Cancer Therapy Clinical Trials 溶瘤病毒癌症治疗临床试验Table of Contents 目录1 1Oncolytic Virus Cancer Therapy Market Key Insights 溶瘤病毒癌症治疗市场关键洞察2 2Oncolytic Virus Cancer Therapy Market Report Introduction 溶瘤病毒癌症治疗市场报告引言3 3Executive Summary of Oncolytic Virus Therapies 溶瘤病毒疗法执行摘要4 4Key Events 关键事件5 五Epidemiology and Market Forecast Methodology 流行病学与市场预测方法论6 6Oncolytic Virus Therapies Market Overview at a Glance in the 7MM 七国市场溶瘤病毒疗法概览6.1 6.1Market Share (%) Distribution by Therapies in 2025 2025年按疗法划分的市场份额（%）分布6.2 6.2Market Share (%) Distribution by Therapies in 2036 2036年按疗法划分的市场份额（%）分布7 7Background and Overview 背景与概述7.1 7.1Introduction 简介7.2 7.2Different Types of Oncolytic Viruses 溶瘤病毒的不同类型7.3 7.3Application of Oncolytic Viruses 溶瘤病毒的应用7.4 7.4Multiple Mechanisms of Action of OVTs for Cancer Therapy 溶瘤病毒疗法在癌症治疗中的多种作用机制7.5 7.5Routes of Administration 给药途径8 8Epidemiology and Target Patient Pool 流行病学与目标患者群体8.1 8.1Key Findings 主要发现8.2 8.2Assumptions and Rationale: 7MM 假设与理由：7MM8.3 8.3Epidemiology Scenario in the 7MM 七大主要市场（7MM）的流行病学情景8.3.1 8.3.1Target Patient Pool of OVTs by Cancer Types in the 7MM 七国市场（7MM）中按癌症类型划分的溶瘤病毒疗法（OVTs）目标患者群体8.4 8.4The United States 美国8.4.1 8.4.1Total Cases of Selected Cancer Types in the United States 美国选定癌症类型的总病例数8.4.2 8.4.2Target Patient Pool of OVTs by Cancer Types in the United States 美国按癌症类型划分的溶瘤病毒疗法目标患者群体8.4.3 8.4.3Treated Cases by Cancer Types in the United States 美国按癌症类型分类的病例治疗情况8.5 8.5EU4 and the UK 欧盟四国与英国8.6 8.6Japan 日本9 9Marketed Oncolytic Viruses 已上市的溶瘤病毒9.1 9.1Marketed Competitive Landscape of Oncolytic Virus Cancer Therapy (OVTs) 溶瘤病毒癌症疗法（OVTs）的市场竞争格局9.2 9.2IMLYGIC (talimogene laherparepvec): Amgen IMLYGIC（塔利莫金拉赫帕雷普韦克）：安进9.2.1 9.2.1Product Description 产品描述9.2.2 9.2.2Regulatory Milestones 监管里程碑9.2.3 9.2.3Others Developmental Activities 其他发展活动9.2.4 9.2.4Ongoing Clinical Developmental Activities 正在进行的临床开发活动9.2.4.1 9.2.4.1Clinical Trial Information 临床试验信息9.2.5 9.2.5Safety and Efficacy 安全性与有效性9.2.6 9.2.6Analyst Views 分析师观点9.3 9.3DELYTACT (G47Δ): Daiichi Sankyo DELYTACT（G47Δ）：第一三共10 10Emerging Oncolytic Viruses 新兴溶瘤病毒10.1 10.1Emerging Competitive Landscape of Oncolytic Virus Cancer Therapy (OVTs) 溶瘤病毒癌症疗法（OVTs）新兴的竞争格局10.2 10.2Olvi-Vec: Genelux Olvi-Vec：Genelux10.2.1 10.2.1Product Description 产品描述10.2.2 10.2.2Other Developmental Activity 其他发展活动10.2.3 10.2.3Clinical Developmental Activities 临床开发活动10.2.3.1 10.2.3.1Clinical Trial Information 临床试验信息10.2.4 10.2.4Safety and Efficacy 安全性与有效性10.2.5 10.2.5Analyst Views 分析师观点10.3 10.3CAN-2409: Candel Therapeutics CAN-2409：Candel Therapeutics10.4 10.4RP1: Replimune RP1：Replimune10.5 10.5Pelareorep: Oncolytics Biotech 佩拉雷奥普：Oncolytics Biotech10.6 10.6Cretostimogene grenadenorepvec: CG Oncology 克雷托刺激基因格雷纳多诺雷普韦克：CG肿瘤公司10.7 10.7CAN-3110: Candel Therapeutics CAN-3110：Candel Therapeutics10.8 10.8LoAd703: Lokon Pharma LoAd703：洛康制药10.9 10.9CF33: Imugene CF33：ImugeneList to be continued… 列表待续……11 十一Oncolytic Virus Market: 7MM analysis 溶瘤病毒市场：七大主要市场分析11.1 11.1Key Findings 主要发现11.2 11.2Oncolytic Virus Cancer Therapy Market Outlook 溶瘤病毒癌症治疗市场展望11.3 11.3Conjoint Analysis 联合分析11.4 11.4Key Oncolytic Virus Cancer Therapy Market Forecast Assumptions 关键溶瘤病毒癌症治疗市场预测假设11.5 11.5Market Size by Indications in the 7MM 七国市场按适应症划分的市场规模11.6 11.6Market Size by Therapies in the 7MM 七大主要市场按疗法划分的市场规模11.7 11.7United States Oncolytic Virus Cancer Therapy Market Size 美国溶瘤病毒癌症治疗市场规模11.7.1 11.7.1Market Size by Indications in the US 美国按适应症划分的市场规模11.7.2 11.7.2Market Size by Therapies in the US 美国按疗法划分的市场规模11.8 11.8EU4 and the UK Oncolytic Virus Cancer Therapy Market Size 欧盟四国及英国溶瘤病毒癌症治疗市场规模11.9 11.9Japan Oncolytic Virus Cancer Therapy Market Size 日本溶瘤病毒癌症治疗市场规模12 十二Unmet Needs 未满足的需求13 13SWOT Analysis SWOT分析14 14KOL Views KOL观点15 十五Market Access and Reimbursement 市场准入与报销15.1 15.1United States 美国15.2 15.2EU4 and the UK 欧盟四国与英国15.3 15.3Japan 日本15.4 15.4Summary and Comparison of Market Access and Pricing Policy Developments in 2025 2025年市场准入与定价政策发展综述及比较15.5 15.5Oncolytic Virus Therapies: Market Access and Reimbursement 溶瘤病毒疗法：市场准入与报销16 十六Bibliography 参考文献17 十七Oncolytic Virus Cancer Therapy Market Report Methodology 溶瘤病毒癌症治疗市场报告方法论Related Reports 相关报告Oncolytic Virus Competitive Landscape 溶瘤病毒竞争格局Oncolytic Virus Competitive Landscape – 2026 溶瘤病毒竞争格局 – 2026report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key oncolytic virus companies, including 本报告提供关于管线格局、管线药物概况（包括临床和非临床阶段产品）以及关键溶瘤病毒公司的全面洞察，包括Genelux Corporation, Candel Therapeutics, CG Oncology, DNAtrix, SillaJen Biotherapeutics, Oncolytics Biotech, Wuhan Binhui Biotechnology, Oryx GmbH, Jiangsu Sinorda Biomedicine Co., Ltd, Virogin Biotech, Replimune, Viralytics, Oncolys Biopharma, Istari Oncology, Immvira Pharma, Seneca Therapeutics, Treovir, LLC, Targovax, Lokon Pharma, ORCA Therapeutics, Beijing SyngenTech, ViruCure, Tasly Pharmaceuticals, Turnstone Biologics, BioInvent, Transgene, Elicera Therapeutics, Orgenesis, Virttu Biologics, Imugene, Astellas Pharma, Wuhan Binhui Biotechnology Co., Ltd., Mustang Bio, Virogin Biotech, Vaxiion Therapeutics, ImmVirX, Memgen, Replimune, Immvira Pharma, ViroCure, GeneMedicine, PsiOxus Therapeutics, VCN Biosciences, Candel therapeutics, Sorrento Therapeutics, Imugene Limited, Calidi Biotherapeutics, Replimune, TILT Biotherapeutics, Guangzhou Virotech Pharmaceutical, DNAtrix, Oncorus, BioEclipse Therapeutics. Genelux公司、Candel Therapeutics、CG Oncology、DNAtrix、SillaJen Biotherapeutics、Oncolytics Biotech、武汉滨辉生物科技、Oryx GmbH、江苏信诺达生物医药有限公司、Virogin Biotech、Replimune、Viralytics、Oncolys Biopharma、Istari Oncology、Immvira Pharma、Seneca Therapeutics、Treovir, LLC、Targovax、Lokon Pharma、ORCA Therapeutics、北京赛金科技、ViruCure、天士力医药、Turnstone Biologics、BioInvent、Transgene、Elicera Therapeutics、Orgenesis、Virttu Biologics、Imugene、安斯泰来制药、武汉滨辉生物科技有限公司、Mustang Bio、Virogin Biotech、Vaxiion Therapeutics、ImmVirX、Memgen、Replimune、Immvira Pharma、ViroCure、GeneMedicine、PsiOxus Therapeutics、VCN Biosciences、Candel Therapeutics、Sorrento Therapeutics、Imugene Limited、Calidi Biotherapeutics、Replimune、TILT Biotherapeutics、广州唯思康药业、DNAtrix、Oncorus、BioEclipse Therapeutics。, and others. ，以及其他。Non-Small Cell Lung Cancer 非小细胞肺癌Market 市场Non-Small Cell Lung Cancer 非小细胞肺癌Market Insights, Epidemiology, and Market Forecast 市场洞察、流行病学及市场预测– –2036 2036report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including 本报告深入解析了该疾病、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和包括以下在内的关键非小细胞肺癌（NSCLC）企业：BeiGene 百济神州, Merus and Partner Therapeutics, Johnson & Johnson Innovative Medicine, Betta Pharma, Xcovery, CStone Pharmaceuticals, Bristol-Myers Squibb, Haihe Biopharma, Taiho Pharmaceutical, Takeda Pharmaceuticals, EMD Serono (Merck KGaA), Eli Lilly and Company, Merck, Regeneron, Sanofi, Ono Pharmaceutical, Novartis, Genentech, Roche, Amgen, Chugai Laboratories, Moderna Therapeutics, Pfizer, GSK . 、Merus和Partner Therapeutics、强生创新药物、贝达药业、Xcovery、基石药业、百时美施贵宝、海河生物制药、大正制药、武田制药、EMD Serono（默克KGaA）、礼来公司、默沙东、再生元、赛诺菲、小野制药、诺华、基因泰克、罗氏、安进、中外实验室、Moderna Therapeutics、辉瑞、葛兰素史克。and others. 以及其他。Melanoma Market 黑色素瘤市场Melanoma 黑色素瘤Market Insights, Epidemiology, and Market Forecast – 2036 市场洞察、流行病学及市场预测 – 2036report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key melanomacompanies including 报告深入解析了该疾病、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和关键黑色素瘤公司，包括IO Biotech, Merck Sharp & Dohme, Eisai, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Spring Bank Pharmaceuticals, Taiga Biotechnologies, Inc., Aivita Biomedical, Inc., Genentech, Inc., Dana-Farber Cancer Institute, BioMed Valley Discoveries, Inc, Amgen, Checkmate Pharmaceuticals, Astellas Pharma Inc, Galectin Therapeutics Inc., Eucure (Beijing) Biopharma Co., Ltd, Mologen AG, Ultimovacs ASA, Seagen Inc., MedImmune LLC, OnKure, Inc., Syntrix Biosystems, Inc., Anaveon AG, iOx Therapeutics, Portage Biotech, ModernaTX, Inc., Nektar Therapeutics, BioNTech SE, Sapience Therapeutics, HUYABIO International, LLC., Provectus Biopharmaceuticals, Inc., Cantargia AB, Turnstone Biologics, Corp., Aura Biosciences, F-star Therapeutics, Inc., Day One Biopharmaceuticals, Inc., Kinnate Biopharma, Xencor, Inc., HiFiBiO Therapeutics. IO Biotech、默沙东（Merck Sharp & Dohme）、卫材（Eisai）、再生元制药（Regeneron Pharmaceuticals）、Iovance Biotherapeutics、Highlight Therapeutics、Linnaeus Therapeutics、Spring Bank Pharmaceuticals、Taiga Biotechnologies, Inc.、Aivita Biomedical, Inc.、基因泰克（Genentech, Inc.）、丹娜法伯癌症研究所（Dana-Farber Cancer Institute）、BioMed Valley Discoveries, Inc.、安进（Amgen）、Checkmate Pharmaceuticals、安斯泰来制药（Astellas Pharma Inc.）、Galectin Therapeutics Inc.、欧凯雷（北京）生物科技有限公司（Eucure (Beijing) Biopharma Co., Ltd）、Mologen AG、Ultimovacs ASA、Seagen Inc.、MedImmune LLC、OnKure, Inc.、Syntrix Biosystems, Inc.、Anaveon AG、iOx Therapeutics、Portage Biotech、ModernaTX, Inc.、Nektar Therapeutics、BioNTech SE、Sapience Therapeutics、HUYABIO International, LLC.、Provectus Biopharmaceuticals, Inc.、Cantargia AB、Turnstone Biologics, Corp.、Aura Biosciences、F-star Therapeutics, Inc.、Day One Biopharmaceuticals, Inc.、Kinnate Biopharma、Xencor, Inc.、HiFiBiO Therapeutics。, ，and others. 以及其他。Pancreatic Cancer Market 胰腺癌市场Pancreatic Cancer 胰腺癌Market Insights, Epidemiology, and Market Forecast – 2036 市场洞察、流行病学及市场预测 – 2036年report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancercompanies including 报告提供对疾病的深入理解、历史及预测的流行病学数据，以及市场趋势、市场驱动因素、市场壁垒和关键的胰腺癌公司，包括FibroGen, OSE Immunotherapeutics, Lokon Pharma, Oncotelic Inc., Tesaro, Inc., Helix BioPharma Corporation, Theradex, Tvardi Therapeutics, Incorporated, AIM ImmunoTech Inc., BioNTech SE, Prestige Biopharma Limited, HCW Biologics, Cantex Pharmaceuticals, XBiotech, Inc., Lumicell, Inc., CARsgen Therapeutics Co., Ltd., Panbela Therapeutics, Inc.. FibroGen、OSE Immunotherapeutics、Lokon Pharma、Oncotelic Inc.、Tesaro, Inc.、Helix BioPharma Corporation、Theradex、Tvardi Therapeutics, Incorporated、AIM ImmunoTech Inc.、BioNTech SE、Prestige Biopharma Limited、HCW Biologics、Cantex Pharmaceuticals、XBiotech, Inc.、Lumicell, Inc.、合源生物技术有限公司（CARsgen Therapeutics Co., Ltd.）、Panbela Therapeutics, Inc., ，and others. 等等。About 关于DelveInsight DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platformPharmDelve. 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上篇围绕RP1联合纳武利尤单抗的上市申请（BLA），深入探讨了RP1的商业化“破局之战”，通过对FDA的审评逻辑与Replimune的答复策略梳理，探析监管机构对溶瘤病毒产品商业化的关键考量。本篇将以这些关键考量为切入点，讨论对后续溶瘤病毒开发所带来的启示。 重视解决未被满足的临床需求 对于处于临床绝境的晚期皮肤黑色素瘤患者而言，RP1的获批，为患者在生死悬崖的边缘，开辟了一条充满希望的生路。也正因为RP1直击未被满足的临床需求，才能够以单臂试验叩开FDA审评联合用药BLA的大门，并最终获得批准。可见，以临床价值为导向、以患者为核心的研发理念，不仅有助于解决未被满足的临床需求，也有利于药物研发机构更快地走通商业化征程。 关键性监管路径的明确与风险揭示 RP1的获批为溶瘤病毒疗法如何走向市场，提供了一条清晰的“加速批准”路径，但也同时揭示了其中的核心难点。以单臂试验的支持创新联合疗法的加速批准，看似设计简单，实则最难，既往成功获批的案例也相对较少。主要因为监管机构对于该路径下单药各自的疗效贡献界定、外部对照数据质量、研究人群治疗现状、药物作用机制是否清晰等方面的要求更严苛。对于一些与溶瘤病毒紧密相关的审评焦点，如瘤内注射疗效评价标准的选择、“非注射病灶”的评估等，申请人需在试验设计之初就审慎规划，尽早与监管机构积极沟通。另外，也要注意临床试验的合规执行，将QbD理念融入到临床试验的执行中，严格把控实施过程及数据管理等关键环节。 尽管RP1上市申请的讨论焦点集中于临床层面，但对溶瘤病毒的商业化而言，CMC同样是决定成败的关键环节。值得关注的是，FDA仅在首封CRL中提及CMC问题，相关缺陷在后续沟通中迅速获得解决。这说明溶瘤病毒商业化生产体系已具备一定的成熟度，工艺和质量的可控性与问题应对能力在实践中得到验证。 从局部治疗到系统性治疗的突破 T-VEC当年申请上市的适应症是用于局部或远端转移性黑色素瘤的注射治疗，但经咨询委员会讨论后，该适应症被限制于局部治疗。主要因为其III期临床的主要终点DRR（WHO标准）为16.3%：对照2.1%，系统效应证据不足。 十一年后，RP1将溶瘤病毒疗法的应用往前推进了一大步。与T-VEC只能注射在“皮肤或皮下浅表结节”不同，RP1除了获批用于非溃疡性/溃疡性浅表肿瘤外，还可在影像技术的引导下用于深部或内脏肿瘤。临床科学家在试验中大量使用超声或CT引导技术，将RP1精准注入患者的肝脏转移灶、肺部或腹腔深部淋巴结，推动了溶瘤病毒科学与介入影像学的深度交叉，展示了溶瘤病毒疗法完全具备对抗深部复杂内脏肿瘤的潜力，如肝癌等。虽然为局部注射，但数据显示患者未注射的远端病灶同样发生了显著缩小，并检测到了系统性T细胞的克隆扩增与活化，这在临床转化医学上实证了溶瘤病毒的“远端效应”，确立了“局部给药、全身获益”在实体瘤生物学上的可行性。这意味着溶瘤病毒的商业价值也将得到进一步提升。 协同增效，解决PD-1耐药难题 RP1是全球首款获批联合疗法的溶瘤病毒，其与PD-1抑制剂纳武利尤单抗联用策略获得了FDA的认可，这验证了溶瘤病毒作为“肿瘤免疫联合疗法最佳搭档”的商业与技术逻辑。RP1与纳武利尤单抗联用时，有助于在那些免疫疗法失效的癌症患者体内恢复抗肿瘤免疫应答，证明了溶瘤病毒不仅可以作为单药，更可以作为一种强大的“组合武器”，把“冷肿瘤”变为“热肿瘤”，协同解决PD-1等免疫检查点抑制剂耐药的问题，这极大地拓展了其市场想象空间。 溶瘤腺病毒OBP-301在日本获批 除了本文提到的RP1外，另外一款为日本Oncolys BioPharma开发的溶瘤腺病毒Telomelysin（通用名：suratadenoturev，代码OBP-301），于2026年6月8日在日本获得完全批准，用于治疗不适合根治性切除或放化疗的食管癌患者。  展  望  2026年是溶瘤病毒赛道颇具里程碑意义的一年，这一年，全球有2款溶瘤病毒获批上市。 可见，随着国内外多家企业积极推进溶瘤病毒的研发工作，溶瘤病毒品种及管线持续增加，不少品种进入中后期临床，并陆续取得突破性进展。当前，全球范围内有70余款溶瘤病毒药物处于临床试验阶段，其中2款（CG0070、CAN-2409）计划今年下半年递交上市申请，3款处于Ⅲ期临床阶段，多款溶瘤病毒进入Ⅱ期临床。据弗若斯特沙利文预测，2026年至2033年全球将有至少10种新型溶瘤免疫疗法获批上市。在国内，根据国家药品审评中心（CDE）官网等披露的数据统计，2015~至今，获批开展临床的溶瘤病毒共有36款，涉及55项IND申请，启动的注册临床有78项，且呈逐年递增的态势。 VG161是一种基于Ⅰ型单纯疱疹病毒（HSV-1）构建的新型抗肿瘤免疫增强型溶瘤病毒，它是全球首个进入临床的携带4个外源性免疫调控基因IL12、IL15/15Rα（IL15和IL15受体α亚基）和PD-L1阻断肽（PDL1B）的溶瘤病毒产品，由中生复诺健从复诺健生物引进。 目前，VG161已进入Ⅱ期临床，在晚期肝细胞癌（HCC）上获得中国突破性治疗品种认定，在美国获得快速通道资格、孤儿药资格认定。VG161的晚期肝细胞癌Ⅰ期临床研究结果已发表于《Nature》。截止投稿日期，研究结果显示，VG161作为三线药物治疗肝癌的总生存期（OS）达到9.4个月，整体疗效与标准二线治疗方案相当。对于既往接受免疫检查点抑制剂治疗超过3个月的患者亚组（占总患者数约2/3)，中位OS更是高达17.3个月，这说明对免疫治疗失败者效果尤佳。 图a. VG161治疗组OS显著优于真实世界对照组 图b. PreCPI>3个月的治疗亚组OS显著优于≤3个月的治疗对照组 此外，VG161联合卡瑞利珠单抗正在晚期HCC中开展Ib/IIa临床研究；截至已发表的ASCO 2025数据截止日，16例入组的末线患者均既往接受过免疫检查点抑制剂治疗。在11例可评价疗效患者中，2例达到部分缓解（PR）、8例达到疾病稳定（SD），ORR为18.2%，中位无进展生存期（PFS）为6.3个月，6个月OS率为87.5%。该结果为“溶瘤病毒+PD-1抑制剂”在既往免疫治疗失败后的患者中提供了进一步的临床探索依据。 “健康中国2030”战略指出 到2030年实现 总体癌症5年生存率提高15% 中生复诺健将持续 深耕溶瘤病毒赛道 为更多患者带来 更好的治疗机会与希望 为循证医学积累 更高质量的证据 参考文献 [1]FDA. FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma. FDA News Release. 2026-08-06. [2]Replimune. Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen. 2026-08-06. [3]Package Insert – TUDRIQEV. [4]FDA. CRL_BLA125827_20250721. [5]FDA. CRL_BLA125827_20260410. [6]Feldman J. FDA Panel Votes 10-3 In Favor of RP1 Plus Nivolumab for Advanced Melanoma. Targeted Oncology. 2026-07-30. [7]Shen Y, Bai X, Zhang Q, et al. Oncolytic virus VG161 in refractory hepatocellular carcinoma. *Nature*. 2025; Published online 19 March 2025. [8]规划司. “健康中国2030”规划纲要. 2017-05-17. 供稿：研发部/临床前注册申报事务室 推荐阅读 1 重磅！《Nature》主刊发表中生复诺健溶瘤病毒VG161治疗晚期原发性肝癌研究成果 2 中生复诺健溶瘤病毒VG161获突破性治疗品种认定 3 溶瘤病毒商业化征程的破局与起势（上）                点个“分享、在看与点赞”吧！